US11382745B2 - Assembly for replacing a heart valve or a coronary angioplasty assembly - Google Patents

Assembly for replacing a heart valve or a coronary angioplasty assembly Download PDF

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US11382745B2
US11382745B2 US16/339,575 US201716339575A US11382745B2 US 11382745 B2 US11382745 B2 US 11382745B2 US 201716339575 A US201716339575 A US 201716339575A US 11382745 B2 US11382745 B2 US 11382745B2
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guide wire
sheath
valve
assembly
electrode
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US20190224011A1 (en
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Benjamin FAURIE
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Electroducer SAS
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Priority claimed from FR1659669A external-priority patent/FR3057153B1/fr
Priority claimed from FR1659671A external-priority patent/FR3057154B1/fr
Priority claimed from FR1659673A external-priority patent/FR3057155B1/fr
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Assigned to ELECTRODUCER reassignment ELECTRODUCER ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FAURIE, Benjamin
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/16—Indifferent or passive electrodes for grounding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3752—Details of casing-lead connections
    • A61N1/3754—Feedthroughs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00039—Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
    • A61B2017/00044—Sensing electrocardiography, i.e. ECG
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22097—Valve removal in veins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22098—Decalcification of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents

Definitions

  • the present invention relates to an assembly for replacing a heart valve by the percutaneous route or to a coronary angioplasty assembly, comprising a valve delivery catheter and, where applicable, an introduction device, commonly called “introducer”.
  • the present invention more specifically relates to the improvement of replacement assistance through cardiac stunning by means of a cardiac stimulator.
  • the assembly according to the invention can be used as a coronary angioplasty assembly that may or may not require the fitting of a prosthesis, which is commonly called “stent”, in particular in an emergency situation or even in complex intervention procedures.
  • a prosthesis which is commonly called “stent”, in particular in an emergency situation or even in complex intervention procedures.
  • the assembly according to the invention also equally can be applicable for the replacement of another valve of the heart, such as the tricuspid valve or the mitral valve.
  • the introducer and/or the delivery catheter of the assembly according to the invention can be inserted inside a patient by the percutaneous route and, more specifically, by the transfemoral route, by the transaortic route, by the carotidian route or by the subclavian route.
  • a widely known heart disease is that which is associated with the narrowing of the tricuspid valve or of the aortic heart valve through calcification, with said aortic heart valve being the valve that separates a heart cavity, namely the left ventricle of the aorta and which, in the open position, allows blood to flow from the heart to the rest of the organism of a human being.
  • Tight or very tight narrowing prevents the aortic valve from opening normally and therefore generates the disease that is also called calcified aortic stenosis.
  • the treatment for this disease involves replacing the defective aortic heart valve.
  • the replacement of a defective aortic heart valve is most often carried out by opening the thorax, subjecting the patient to extracorporeal circulation, implementing temporary cardiac arrest, and opening the heart, in order to remove and replace the native valve with an artificial valve or prosthesis.
  • the native aortic heart valve that is defective due to calcification is replaced by an artificial valve while avoiding the normal previously described major heart surgery intervention.
  • Fitting an artificial valve currently can be performed by various percutaneous routes: by the transfemoral route, i.e. by introduction from the femoral artery to the heart, or by the transapical route or by the transaortic route, or by the carotidian route or even by the subclavian route, i.e. any route requiring neither an open-heart operation through opening of the thorax nor extracorporeal circulation.
  • an artificial valve which replicates the general shape of a normal native aortic valve, at the level of the calcified (diseased) native aortic valve, with said valve being left in place and crushed by the prosthesis.
  • the artificial valve formed as a pericardium which is the fine membrane surrounding the heart, of porcine or bovine origin, is previously fixed inside a radially extendable tubular metal mesh, called “stent”, and is formed by assembling wires made of shape memory material, for example, made of nickel-titanium or cobalt-chromium alloy, or 316L stainless steel for coronary stents.
  • valve-stent assembly is then compressed outside a tubular sheath, called delivery catheter, which can be introduced either directly into an artery or inside an introducer allowing access to the artery whilst maintaining hemostasis.
  • delivery catheter a tubular sheath
  • valve-stent assembly slides into the introducer or directly into the delivery catheter until said assembly reaches the diseased aortic valve.
  • the valve-stent assembly is subsequently deposited in the vicinity of the diseased valve by expanding a balloon before fitment.
  • Valve delivery catheters also exist that comprise a valve-stent assembly without a balloon, in which the valve is self-expandable, which allows the valve to be deposited, which expands radially through simple withdrawal of the sheath surrounding it and therefore without having to previously expand a balloon.
  • the heart needs to be temporarily stopped for a short period of time through rapid ventricular stimulation in order to minimize the transvalvular, i.e. between valvules, flow rate and to prevent, and at the very least to reduce, potential embolization.
  • This temporary stopping of the heart also commonly called “cardiac stunning”, thus involves causing the heart to voluntarily beat at 150 to 200 beats per minute so that there is no longer effective contraction, which causes a drop in pressures and stimulates tachycardia or ventricular fibrillation and therefore a stabilization of the heart.
  • This stabilization of the heart allows the balloon to be stabilized and therefore allows an increase in the precision of the fitting of the artificial valve in a matter of seconds.
  • Bipolar stimulation catheters exist with two electrodes, called drive or electro-systolic stimulation probes, for temporary endocardiac stimulation of the right ventricle.
  • electro-systolic stimulation probes have a certain number of disadvantages that are described hereafter.
  • this probe is relatively rigid, and for this reason fitting it into the right ventricle, which is fragile and the wall of which is thinner than that of the left ventricle, results in a consequential risk of the phenomenon that is well known to interventional physicians as “tamponade”, which means a significant circulatory deficiency that can lead to the death of the patient.
  • a stimulation probe is not fastened to a wall of the heart and therefore can move and thus result in a loss of capture of the electrical stimulation signal.
  • the heart is then no longer stimulated and therefore has significant movements that disrupt the placement of the valve or of the balloon.
  • Publication [2] emphasizes the advantages of performing this ventricular stimulation on the left ventricle and not on the right ventricle and of performing this operation not by means of a specific stimulation catheter by the transvenous route, but by implementing an external cardiac stimulator with the guide wire used for interventions of this type.
  • the recommended practice that is disclosed in this publication [2] involves using the guide wire, which supports the expansion balloon of the stent and is introduced into the left ventricle, as a part connected to the cathode of a cardiac stimulator and a cutaneous electrode or needle inserted in the subcutaneous tissue, as a support for the anode of the cardiac stimulator.
  • Publications [3] and [4] confirm, in the event of a coronary angioplasty intervention on a porcine population, the effectiveness of a temporary cardiac stimulation with a lower electrical stimulation voltage, by implementing the guide wire supporting the expansion balloon of the stent, as a part connected to the cathode of a cardiac stimulator and of a cutaneous electrode or needle inserted in the subcutaneous tissue, as a support for the anode of the cardiac stimulator.
  • the advantages of these recommended practices involve avoiding having to insert an additional dedicated catheter, avoiding additional access to the heart, reducing the time and the cost of the operation, but also reducing the level of complications associated with the insertion of the dedicated catheter, all the while allowing equally effective stimulation as by means of a stimulation by the transvenous route.
  • the guide wire that is used for this technique is very stable and comes into permanent abutment against the wall of the relatively thick left ventricle, since it acts as a rail for advancing the stent-balloon-valve assembly through the valve.
  • patent application WO2016/162315 discloses and claims the integration of an electrode of a cardiac stimulator directly into the introduction sheath (introducer or delivery catheter) in the artery of a patient.
  • the proposed invention makes it easier and quicker to fit and handle cardiac stimulator electrodes for the surgeon(s) responsible for the operation.
  • the aim of the invention is to at least partly address this requirement.
  • the aim of the invention is an assembly for replacing a heart valve by the percutaneous route, comprising:
  • the aim of the invention is an assembly for replacing a heart valve by the percutaneous route, comprising:
  • the electrode of the cardiac stimulator connected to the electrically conductive sleeve fitted around the introduction sheath of the introducer or of the delivery catheter is the anode, whereas that which is connected to the metal part of the guide wire is the cathode.
  • a further aim of the invention is an electrically conductive sleeve intended for an assembly as previously described.
  • the sleeve can be formed by a one-piece part made of conductive material, such as carbon.
  • It also can be formed by a sheath comprising an electrically conductive coating, such as a carbon coating, on the outer periphery thereof.
  • the sleeve can be resilient so as to be able to be fitted onto sheaths for introducers or delivery catheters with different diameters, typically with outer diameters between 1.67 and 8 mm (between 5 and 24 French gauge).
  • the outer diameters can be 4 mm, 4.67 mm, 5.33 mm or even 6 mm for sheaths intended for heart valve replacement assemblies.
  • the invention relates to an assembly for replacing a heart valve by the percutaneous route, comprising:
  • the aim of the invention is an assembly for replacing a heart valve by the percutaneous route, comprising:
  • the electrode of the cardiac stimulator connected to the transcutaneous electrode is the anode, whereas that which is connected to the metal part of the guide wire is the cathode.
  • a further aim of the invention is a transcutaneous electrode, intended for an assembly as previously described.
  • a further aim of the invention is an assembly for replacing a heart valve by the percutaneous route, comprising:
  • the aim of the invention is an assembly for replacing a heart valve by the percutaneous route, comprising:
  • the electrode of the cardiac stimulator connected to the electrically conductive element integrated in the sheath of the guide wire is the anode, whereas that which is connected to the metal core of the guide wire is the cathode.
  • the metal conductive element is a metal layer embedded in the isolating sheath, except for its apparent distal and proximal portions.
  • the non-electrically isolated distal end of the metal core of the guide wire intended to come into contact with the wall of the left ventricle of the heart of a patient is a portion that is more flexible than the remainder of the guide wire.
  • the more flexible portion is adapted to wrap around itself when it comes into contact with the wall of the left ventricle of the heart of a patient.
  • the distal portion of the conductive element can be connected to an electrical connection, which is intended to be connected to an electrode of the cardiac stimulator outside the body.
  • a further aim of the invention is a bipolar guide wire intended for an assembly as previously described.
  • a bipolar guide wire comprises a metal core coated with an electrically isolating sheath on a central portion between the proximal end and the distal end of the guide wire, the metal core being non-electrically isolated on the remainder of the length of the guide wire, the electrically isolating sheath integrating an electrically conductive element, for which a distal portion is apparent on at least one part of the outer periphery of the isolating sheath and for which a proximal portion is also apparent on at least one part of the outer periphery of the isolating sheath.
  • the inventor also considered integrating the metal support of an electrode of the cardiac stimulator into a part fitted around the introduction sheath that is introduced into the artery of a patient.
  • the sleeve according to the invention therefore is in direct contact with the artery of the patient.
  • the inventor considered integrating the metal support of an electrode of the cardiac stimulator, not directly into the introduction sheath in the artery of a patient as in the aforementioned application, but into a guide wire.
  • the bipolar guide wire according to the invention on its own acts as a support for the two electrical connections respectively connected to the anode and to the cathode of an external cardiac stimulator.
  • the metal core acts as a support for one of the electrical connections
  • the proximal portion of the conductive element which is isolated from the metal core, acts as a support for the other one of the electrical connections.
  • Cardiac stunning thus can be performed by bipolar electrical stimulation, the advantage of which is that it requires a very low electrical stimulation threshold.
  • the introduction sheath can be that of an introducer or directly that of a delivery catheter, which is smaller compared to an introducer.
  • a valve delivery catheter does not de facto require an introducer since it can be introduced directly into the artery of a patient.
  • a needle no longer needs to be inserted in the subcutaneous tissues or a cutaneous electrode in order to act as a support for the electrode, typically the anode of a cardiac stimulator.
  • the stimulation intensity required for cardiac stunning is lower than in the solutions of the prior art, due to a lower impedance of the vascular system relative to the subcutaneous tissue.
  • the intensity of the current delivered with a view to cardiac stunning can range from 10 to 20 mA and the delivered voltage can range from 0.5 to 10 Volt.
  • the surgeon(s) responsible for the operation thus can easily connect the electrode, typically the anode of the cardiac stimulator, to the conductive sleeve fitted around the introducer or the delivery catheter or even the transcutaneous electrode or even the bipolar guide wire, then connect the other electrode as normal, typically the cathode to the guide wire of the valve-stent-balloon or self-expanding-valve-stent assembly.
  • the step of preparing for heart stoppage is easier and quicker to implement.
  • a sleeve or a transcutaneous electrode or a bipolar guide wire according to the invention can reduce the risks of complications associated with the electro-systolic stimulation probes of the prior art that are placed in the right ventricle.
  • the introducer or the delivery catheter can be introduced by the transapical route or by the transfemoral route as normal, which route is preferred due to its less invasive nature for weaker patients.
  • the introducer or the delivery catheter can integrate a peripheral perfusion system, commonly called “flush” system, which can be fitted to clean any blood clots out of the inside of the introducer or the catheter that are likely to be present therein.
  • flush peripheral perfusion system
  • the introducer can be a known introducer, for example, that with the “Edwards eSheath introducer sheath set” trade name, marketed by Edwards Lifesciences.
  • the artificial valve can be introduced and positioned in the artery by means of a conventional catheter valve, which is introduced into the introducer.
  • the artificial valve then assumes a folded position and does not obstruct the introduction and sliding of the catheter valve into the introducer and then into the artery, or into the delivery catheter according to the invention, and then into the artery.
  • the artificial valve comes into abutment against the outer wall of the native heart valve in place of said valve by crushing said valve.
  • a conventional catheter valve thus allows the artificial valve to be introduced and positioned at the suitable location, using the same operating movement as that which allows the native valve to be opened and crushed. Following the opening and crushing of said native valve, the catheter valve is caused to axially slide in the distal direction in order to convey the artificial valve to the appropriate level in the opening of the native valve.
  • the surgeon(s) operating on the patient applies, during the opening and crushing of the native valve, then afterwards, a cardiac stimulation by means of the external cardiac stimulator, with the electric current circulating between the cathode and the anode of the stimulator, the cathode being connected to the guide wire of the artificial valve and the anode being connected to the conductive sleeve according to the invention, which is fitted around the external tubular sheath of the introducer or of the delivery catheter and is in contact with the subcutaneous tissue of the patient or with the inner wall of the artery.
  • the artificial valve is deployed at the same time as the ventricular stimulation.
  • the catheter valve is then withdrawn.
  • the only relative limitation of the sleeve, of the transcutaneous electrode or of the bipolar guide wire according to the invention is at the start of the operation, during preparation, and involves fitting the sleeve around the introduction sheath.
  • this operation is very simple and easy to implement and quite possibly can be performed by an assistant or a nurse, without them requiring special skills for this task.
  • a further aim of the invention is the use of the assembly with an introducer or delivery catheter with a sleeve as previously described for replacing an aortic, pulmonary, tricuspid or mitral valve.
  • the aim of the invention is the use of the assembly with an introducer or delivery catheter with a sleeve as previously described for a coronary angioplasty intervention, particularly in an emergency situation.
  • This use is particularly advantageous in three intervention situations that can be encountered in coronary angioplasty.
  • the first situation is the treatment of an acute heart-attack that would result in conduction problems of the extreme bradycardia type or a major auriculo-ventricular blockage.
  • Using an introducer with a sleeve according to the invention avoids the use of an electro-systolic probe according to the prior art, which is much more invasive and requires a significant added implantation time.
  • the second situation relates to the treatment of calcified coronary lesions by burring that is carried out inside the coronaries in question, normally using a burring device known under the “Rotablator®” trade name.
  • Using an introducer with a conductive sleeve according to the invention then also overcomes having to use an electro-systolic cardiac stimulation probe as in the prior art.
  • the third situation relates to the fitting of a stent, in certain parts of the coronaries in the vicinity of their sources (ostia), these zones are very mobile in relation to the intervention catheter, while these anatomic zones require very high precision when implanting the stent.
  • Using an introducer with a conductive sleeve according to the invention allows the stent to be stabilized before and during its fitting.
  • FIG. 1 is a perspective view of an introducer according to the prior art intended to be introduced into a femoral artery in the groin of a patient;
  • FIGS. 2A to 2C show a partial longitudinal section view of various steps of sliding a catheter valve into the introducer according to FIG. 1 , in order to fit an artificial valve in place of a defective native aortic valve;
  • FIG. 3 shows a schematic perspective view, from outside a patient, both of the step of fitting a catheter valve and of fitting cardiac stimulation electrodes according to the prior art
  • FIG. 4 is a schematic perspective view of a delivery catheter according to the prior art intended to be introduced directly into the artery of a patient without requiring an introducer;
  • FIG. 5 is a perspective view of an electrically conductive sleeve according to the invention intended to be fitted around a device forming an introducer according to the prior art, such as that shown in FIG. 1 , or around a delivery catheter according to the prior art, such as that shown in FIG. 4 ;
  • FIG. 6 is a partial longitudinal section view showing a sleeve according to FIG. 5 fitted around an introducer according to the prior art, such as that shown in FIG. 1 ;
  • FIG. 7 is a perspective view of a transcutaneous electrode intended to be used in an assembly for replacing a heart valve by the percutaneous route, in order to achieve cardiac stunning;
  • FIG. 8 shows a schematic perspective view, from outside a patient, both of the step of fitting a catheter valve and of fitting cardiac stimulation electrodes according to the invention
  • FIG. 9 is a perspective view of a bipolar guide wire according to the invention intended to be used in an assembly for replacing a heart valve by the percutaneous route, in order to achieve cardiac stunning;
  • FIGS. 9A and 9B are transverse section views along A-A and along B-B, produced at the level of the distal and proximal portion, respectively, of the electrically conductive element embedded in the isolating sheath of the bipolar guide wire according to FIG. 9 ;
  • FIG. 10 shows a section view of the formation of the central portion of the bipolar guide wire according to the invention.
  • FIG. 11 shows a schematic perspective view, from outside a patient, both of the step of fitting a catheter valve and of fitting cardiac stimulation electrodes according to the invention.
  • distal and proximal are used with reference to the body of a patient, for which the defective native aortic valve is replaced by an artificial aortic valve.
  • distal end of an introducer is the end located farthest inside the patient during the replacement operation.
  • FIG. 1 shows an introducer 1 for replacing a heart valve by the transfemoral route.
  • This introducer 1 which is of general tubular shape, comprises, between the proximal end 10 and the distal end 11 thereof, an end piece 12 extended by at least one external tubular sheath 13 formed by two tubular portions 14 , 15 from the proximal side toward the distal side, considered in relation to the introduction into a femoral artery of a patient to be operated on, i.e. from top-to-bottom in FIG. 1 .
  • the end piece 12 generally integrates a set of sealed valves for achieving hemostasis, i.e. to ensure that blood is maintained inside the blood vessels of the patient during the operation.
  • the tubular sheath 13 may or may not be extendable in order to allow through a surgical intervention device such as a catheter valve, as explained hereafter.
  • the constituent material of the sheath 13 is a biocompatible material, such as silicon. It equally can be made of TeflonTM or of polyurethane.
  • the outside of the sheath advantageously can be covered with a hydrophilic layer and the inside can be covered with a material with a low friction coefficient in order to facilitate the sliding of an intervention device.
  • the introducer 1 shown in FIG. 1 also comprises a tapped rinsing device 16 , commonly called “flush” device, that is integrated in order to rinse the inside of the introducer 1 using a suitable rinsing liquid.
  • a tapped rinsing device 16 commonly called “flush” device
  • All the elements of the introducer 1 present in the proximal or external zone Z E are intended to remain outside the body of the patient, the entirety of the distal portion 15 of the sheath 13 defining the distal zone Z 1 is intended to be introduced into a femoral artery of a patient.
  • the introducer 1 that is shown is, for example, that which is marketed under the “Edwards eSheath introducer sheath set” trade name, marketed by Edwards Lifesciences.
  • FIGS. 2A to 2C show the progression of a catheter valve 2 formed by a guide wire 20 and an assembly 21 formed by an artificial valve fixed to a radial expansion stent and a balloon that can be inflated to provide this expansion, inside the distal portion 14 of the tubular sheath of the introducer 1 already introduced into a femoral artery A.
  • the tip of the assembly 21 enables easy penetration into the defective native aortic valve.
  • FIG. 3 shows that the hand M of a surgeon introduces the catheter valve 2 into the introducer 1 already introduced into the femoral artery of a patient, with the end piece 12 projecting outside the body C.
  • This introduction of the catheter valve 2 allows the assembly 21 to be brought level with the defective calcified aortic valve that needs to be replaced.
  • a clip 3 is fixed by clipping onto the guide wire 20 of the catheter valve 2 .
  • This clip 3 is connected to the cathode of a cardiac stimulator (not shown) located outside the body C.
  • a needle (not shown) is also inserted in the subcutaneous tissues of the body C of the patient to be operated on.
  • a metal wire 4 is fixed on this needle.
  • a crocodile type clip 5 is also fixed by clipping onto the metal wire 4 .
  • This clip 5 is connected to the anode of the cardiac stimulator outside the body.
  • the surgeon performs, prior to the actual fitting of the artificial valve, i.e. the inflation of the balloon and therefore the expansion of the stent to which the valve is fixed, a rapid ventricular stimulation of the left ventricle.
  • an electrical signal is delivered between the cathode and the anode by means of the clips 3 , 5 , with the balloon acting as an electrical isolator between these two electrodes.
  • FIG. 4 shows a delivery catheter 1 ′ that can be introduced directly into the artery of a patient without requiring an introducer. More specifically, the catheter 1 ′ comprises an end piece 12 extended by an introduction sheath 13 . The end piece 12 comprises a connection 18 for inflating/deflating a balloon 7 at the distal end 11 , which allows a prosthetic valve (not shown) to be expanded.
  • the inventor firstly considered integrating the function of the metal wire not in a specific introducer or delivery catheter, but for an electrically conductive sleeve 6 to be produced that is adapted to be fitted directly around an existing introducer 1 or delivery catheter 1 ′.
  • FIG. 5 Such a sleeve 6 according to the invention is shown in FIG. 5 : it is shown in the form of a tube, at least one part of the outer periphery of which is electrically conductive.
  • This conductive part is connected to an electrical connection 8 by means of an electrical power supply wire 7 .
  • the sleeve 6 can be of cylindrical shape or can have a conical section. Its shape matches the external shape of the introduction sheath 13 of an introducer 1 or a catheter 1 ′ as closely as possible.
  • this sleeve 6 which is typically approximately one millimeter or less, only adds a slight over-thickness to the sheath 13 and therefore does not hinder the progression thereof when it is introduced into an artery A.
  • the sleeve 6 can be produced in the form of a fully conductive one-piece part or in the form of a part coated with an electrically conductive coating.
  • carbon can be selected as the electrically conductive material.
  • the sleeve 6 can be designed so that it is resilient and so that it can thus adapt to any size of existing introducer or delivery catheter.
  • a surgeon or interventional physician wishing to undertake an operation for replacing a heart stimulation valve with cardiac stimulation accompanying the fitting of the prosthetic valve begins by fitting the conductive sleeve 6 around the introducer 1 or the delivery catheter 1 ′.
  • fitting the conductive sleeve is very simple and easy, it can be undertaken by an assistant or a nurse without them having to adopt any particular technique.
  • Fitting is complete once the sleeve 6 is fitted and arranged around the introduction sheath 13 so that it comes into contact either with a subcutaneous zone of the patient or with the wall of the aortic artery of the patient.
  • the introduction of the introducer 1 or of the delivery catheter 1 ′ with the sleeve 6 around the sheath can be completed normally by the surgeon.
  • the electrical connection 8 can be connected directly to the anode of an external cardiac stimulator.
  • a clip such as the crocodile clip 3 shown in FIG. 3
  • a clip can be fixed by clipping onto the guide wire of an introducer 1 or of a catheter valve 1 ′.
  • This clip is connected to the cathode of the cardiac stimulator (not shown), located outside the body C.
  • the temporary cardiac stimulation for achieving the desired cardiac stunning can occur between the cathode electrically connected to the guide wire and the anode electrically connected to the sleeve 6 according to the invention.
  • the inventor has also considered integrating the function of the metal wire not in a specific introducer or delivery catheter, but for a transcutaneous electrode 6 ′ to be used instead.
  • Such an electrode 6 ′ according to the invention is shown in FIG. 7 : it comprises an adhesive part 60 ′ intended to be adhered to the skin of the human body into which the sheath is introduced, and a part 61 ′ made of electrically conductive material adapted to deliver a current transcutaneously.
  • the part 61 ′ made of conductive material further comprises an electrical connection, including an electrical power supply wire 7 ′ rigidly connected to a connector 8 in order to complete the connection with an electrode of an external cardiac stimulator.
  • a surgeon or interventional physician wishing to undertake an operation for replacing a heart stimulation valve with cardiac stimulation accompanying the fitting of the prosthetic valve begins by adhering the transcutaneous electrode 6 to the skin of the patient.
  • This electrode can be fitted, for example, in a zone facing the heart.
  • fitting is very simple and easy, it can be undertaken by an assistant or a nurse without them having to adopt any particular technique.
  • the surgeon can introduce the introducer 1 or the delivery catheter 1 ′ as normal.
  • the electrical connection 8 can be connected directly to the anode of an external cardiac stimulator.
  • a clip such as a crocodile clip 3
  • a clip can be fixed by clipping onto the guide wire of an introducer 1 or of a catheter valve 1 ′.
  • This clip is connected to the cathode of the cardiac stimulator (not shown), located outside the body C.
  • FIG. 8 Such a configuration is shown in FIG. 8 .
  • the temporary cardiac stimulation for achieving the desired cardiac stunning can occur between the cathode electrically connected to the guide wire and the anode electrically connected to the transcutaneous electrode 6 ′ according to the invention.
  • the inventor considered integrating the function of the metal wire not in a specific introducer or delivery catheter, but in a bipolar guide wire 6 ′′ with electrical isolation on its central portion, with the guide wire still being intended to be introduced into the tubular sheath 13 of the introducer.
  • the bipolar guide wire 6 ′′ firstly comprises a metal core 60 ′′ coated with an electrically isolating sheath 61 ′′ on a central portion between the proximal end 6 P′′ and the distal end 6 D′′ of the guide wire.
  • the distal end 6 D′′ of the metal core is intended to come into contact with the wall of the left ventricle of the heart of a patient.
  • this distal end 6 D′′ is a more flexible portion than the remainder of the guide wire, with its flexibility allowing it to wrap around itself when it comes into contact with the wall of the left ventricle of the heart of a patient. This thus ensures contact that is both secure and non-impacting, i.e. that does not risk perforating the wall of the ventricle, contrary to the electro-systolic stimulation probes according to the prior art, with which contact is quasi-punctual contact with the wall, which generates a risk of tamponade.
  • the metal core 60 ′′ is non-electrically isolated on the remainder of the length of the guide wire.
  • a metal layer 7 ′′ is embedded inside the electrically isolating sheath 61 ′′, with the exception of the distal 70 ′′ and proximal 71 ′′ portions thereof.
  • the distal portion 70 ′′ is apparent over the entire outer periphery of the isolating sheath 71 ′′ in order to be in contact with the subcutaneous tissue of the body or with the artery.
  • the proximal portion 71 ′′ is apparent over the entire outer periphery of the isolating sheath in order to be accessible from outside the body C when the guide wire is introduced into the introduction sheath 13 .
  • the proximal portion 71 ′′ of the integrated conductive element 7 ′′ acts as a connection to an electrode of a cardiac stimulator outside the body, whereas the metal core 60 ′′ of the bipolar guide wire acts as a connection to the other electrode of the external cardiac stimulator.
  • a surgeon or interventional physician wishing to undertake an operation for replacing a heart stimulation valve with cardiac stimulation accompanying the fitting of the prosthetic valve begins by introducing the introducer 1 or the delivery catheter 1 ′, which can be undertaken by the surgeon as normal.
  • the bipolar guide wire 6 ′′ according to the invention is then introduced into the introduction sheath 13 of the introducer 1 or of the delivery catheter 1 ′.
  • the proximal portion 71 ′′ of the conductive element 7 ′′ can be connected directly to the anode of an external cardiac stimulator.
  • a clip 5 such as a crocodile clip 3
  • This clip 3 is connected to the anode of the cardiac stimulator (not shown), located outside the body C.
  • a clip such as a crocodile clip 5
  • a clip can be fixed by clipping onto the metal core 60 ′′ of the guide wire 6 ′′.
  • This clip 5 is connected to the cathode of the cardiac stimulator (not shown), located outside the body C. Such a configuration is shown in FIG. 11 .
  • the temporary cardiac stimulation for achieving the desired cardiac stunning can occur between the cathode electrically connected to the metal core 60 ′′ of the guide wire 6 ′′ according to the invention and the anode electrically connected to the distal portion 71 ′′ of the conductive element 7 ′′ of the guide wire 6 ′′.
  • the invention allows all the advantages to be maintained that are inherent with the invention according to application WO2016/162315 for replacing a heart valve by the percutaneous route, with the additional advantage of being able to be implemented in any existing introducer or delivery catheter, since the following can be selected:

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US16/339,575 2016-10-07 2017-10-05 Assembly for replacing a heart valve or a coronary angioplasty assembly Active 2038-01-30 US11382745B2 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
FR1659669 2016-10-07
FR1659673 2016-10-07
FR1659671 2016-10-07
FR1659669A FR3057153B1 (fr) 2016-10-07 2016-10-07 Manchon conducteur electrique pour catheter de delivrance ou introducteur d'un ensemble de remplacement d'une valve cardiaque ou d'un ensemble d'angioplastie coronaire
FR1659671A FR3057154B1 (fr) 2016-10-07 2016-10-07 Electrode transcutanee pour ensemble de remplacement d'une valve cardiaque ou ensemble d'angioplastie coronaire comprenant un catheter de delivrance ou un introducteur
FR1659673A FR3057155B1 (fr) 2016-10-07 2016-10-07 Guide-fil bipolaire pour ensemble de remplacement d'une valve cardiaque ou ensemble d'angioplastie coronaire comprenant un catheter de delivrance ou un introducteur
PCT/EP2017/075362 WO2018065523A1 (fr) 2016-10-07 2017-10-05 Ensemble de remplacement d'une valve cardiaque ou d'un ensemble d'angioplastie coronaire

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US20190224011A1 US20190224011A1 (en) 2019-07-25
US11382745B2 true US11382745B2 (en) 2022-07-12

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US9554897B2 (en) 2011-04-28 2017-01-31 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US9308087B2 (en) 2011-04-28 2016-04-12 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US9345573B2 (en) 2012-05-30 2016-05-24 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US9572665B2 (en) 2013-04-04 2017-02-21 Neovasc Tiara Inc. Methods and apparatus for delivering a prosthetic valve to a beating heart
CN108882981B (zh) 2016-01-29 2021-08-10 内奥瓦斯克迪亚拉公司 用于防止流出阻塞的假体瓣膜
EP3541462A4 (fr) 2016-11-21 2020-06-17 Neovasc Tiara Inc. Procédés et systèmes de rétraction rapide d'un système de pose de valvule cardiaque transcathéter
EP3672530A4 (fr) 2017-08-25 2021-04-14 Neovasc Tiara Inc. Prothèse de valvule mitrale transcathéter à déploiement séquentiel
FR3079404B1 (fr) * 2018-03-29 2020-03-06 Electroducer Ensemble de remplacement d’une valve cardiaque avec assistance de stimulation par voie arterielle ou veineuse peripherique
EP3876870B1 (fr) 2018-11-08 2023-12-20 Neovasc Tiara Inc. Déploiement ventriculaire d'une prothèse de valvule mitrale transcathéter
US11998447B2 (en) 2019-03-08 2024-06-04 Neovasc Tiara Inc. Retrievable prosthesis delivery system
JP7438236B2 (ja) 2019-04-01 2024-02-26 ニオバスク ティアラ インコーポレイテッド 制御可能に展開可能な補綴弁
CA3136334A1 (fr) 2019-04-10 2020-10-15 Neovasc Tiara Inc. Valvule prothetique a circulation sanguine naturelle
CN114025813B (zh) 2019-05-20 2024-05-14 内奥瓦斯克迪亚拉公司 具有止血机构的引入器
WO2020257643A1 (fr) 2019-06-20 2020-12-24 Neovasc Tiara Inc. Valve mitrale prothétique à profil bas
FR3118865B1 (fr) 2021-01-19 2023-02-10 Electroducer Ensemble de diagnostic coronaire avec guide-fil servant à la fois pour l’assistance de stimulation cardiaque et la mesure de la réserve coronaire.
US11872403B2 (en) 2021-08-06 2024-01-16 Solo Pace Inc. Systems, methods, and apparatus for external cardiac pacing
EP4380678A1 (fr) 2021-08-06 2024-06-12 Solo Pace Inc. Systèmes, procédés et appareil de stimulation cardiaque externe

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EP3522800B1 (fr) 2021-07-14
JP2019533501A (ja) 2019-11-21
EP3522800A1 (fr) 2019-08-14
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WO2018065523A1 (fr) 2018-04-12
ES2892273T3 (es) 2022-02-03

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